Submission Details
| 510(k) Number | K250117 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 16, 2025 |
| Decision Date | February 13, 2025 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette
Feb 2025
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K250117 is an FDA 510(k) clearance for the FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette, a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II — Special Controls, product code LCX), submitted by Assure Tech., LLC (Wilmington, US). The FDA issued a Cleared decision on February 13, 2025, 28 days after receiving the submission on January 16, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.
Device Classification
| Product Code | LCX — Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1155 |
Manufacturer
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